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Institutional
Bio-Safety Committee (IBC)
LSUHSC-NO’s
Institutional Bio-safety Committee (IBC) acts as the framework for risk
management associated with research-related, bio-safety issues. The
committee works in concert with the LSUHSC-NO Office of Environmental
Health and Safety and the Office of Research Services The
objectives of this risk management program are threefold: 1)
To assure that the Institution is in compliance with all state and
federal regulatory agency bio-safety requirements, 2) To review
projects for use of “Select Agents” under the Select Agents Program of
DHHS and USDA and/or “Dual use items” under export control regulations of
the Department of Commerce, and 3) To protect individuals and research
animals from potential dangers in the use of or exposure to such
things as pathogens, organs or tissues of biological origin, genetic
therapy products, transgenic genes, bacteria, viruses, prions and
chemicals and toxins that may affect health. The program is also
used to verify and track required bio-safety training as mandated by the
state Office of Risk Management. Note that all research projects
must be submitted for IBC review to allow a determination of whether all
bio-safety concerns are resolved or managed, or that the project is
exempt from further IBC oversight. Both IRB and IACUC approval are
contingent upon IBC review and approval.
IBC Policies and Procedures
IBC Forms
The Principal Investigator must
submit all forms electronically by emailing the IBCoffice@lsuhsc.edu . Mail only the signature page of initial
applications (Section F) to the IBC Office at 433 Bolivar Street, Room
206, New Orleans, LA 70112. Initial applications, amendments and annual
reviews are processed as received.
IBC Protocol Submittal Form for initial
application and amendments
IBC Annual Update Form for
re-approval and adding new personnel
LSUHSC-NO Environmental Health and Safety (EH&S)
EH&S Safety Training
"Select
Agents" and "Dual Use" Items
As
listed and described at the following two websites, there are potential
reporting and licensing requirements for the use of certain pathogens and
toxins. You should be aware of these regulations and must report to the
Office of Research Services (ORS) and the Office of Environmental Health
and Safety (EH&S) the possession and use of such agents/items. The
ORS and EH&S will help you with any regulatory requirements related
to such issues.
DHHS (CDC) and USDA (APHIS) - Select Agents Program
The
National Select Agent Registry Program oversees the activities of
possession of biological agents and toxins that have the potential to
pose a severe threat to public, animal or plant health, or to animal or
plant products. Depending on quantities, there may be reporting
requirements for the possession and use of certain agents.
Department of Commerce - Export Administration
Regulations (EAR) and Commerce Control List (CCL)
The CCL
contains items that are considered “Dual Use” items, i.e., used for
commerce/research and could be used as a potential bio-terrorist weapon.
Depending on the circumstances there may be limitations on the use and
licensing requirements of such items.
International Traffic in Arms Regulations (ITAR)
This
set of federal (US State Department) regulations limits the export of
military defense articles and services. While it is unlikely that any activities
conducted at the Health Sciences Center will be subject to these
regulations, there are situations where the institution must certify to
that effect, e.g., I-129 visa applications. Be aware that the US Munitions List (ITAR Part 121) has a
section (Category XIV) that includes toxilogical agents, including
chemical agents, biological agents, and associated equipment that might
be used by our investigators. Items on the list that are a) designed,
developed, configured, adapted, or modified for a military application,
and do not have a predominant civil application and do not have performance
equivalent (defined by form, fit and function) to those of an article or
service used for civil applications; or b) are specifically designed,
developed, configured, adapted , or modified for a military or
intelligence applicability such that control under this ITAR is necessary
fall under the ITAR regulations. You must notify the ORS immediately if
any of your work is subject to ITAR and involves any item on the US
Munitions List.
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